510(k) K062611
K062611 is an FDA 510(k) premarket notification submitted by Medical Intelligence Medizintechnik-GmbH-An Elekta for the device "IGUIDE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 2006. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medical Intelligence Medizintechnik-GmbH-An Elekta has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2006
- Date Received
- September 5, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type